Condition category
Mental and Behavioural Disorders
Date applied
04/06/2014
Date assigned
13/06/2014
Last edited
30/07/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Many heavy drinkers want to reduce their drinking but most do not seek treatment, which puts them at risk of health problems and alcohol dependence. Barriers to standard treatments include availability and cost. The inability to stop inappropriate behaviour (disinhibition) plays a causal role in heavy drinking. Recent research suggests that computerised training tasks that improve inhibition lead to reductions in alcohol consumption, at least in the short-term. Internet interventions (E-health) can overcome traditional barriers to treatment. The aim of this study is to find out about the effectiveness of different forms of inhibition training delivered via the Internet, for the reduction of alcohol consumption in problem drinkers.

Who can participate?
Heavy drinkers aged between 25-65 who are motivated to cut down their alcohol consumption. Participants are required to have an email address and access to the internet.

What does the study involve?
Participants will attend the test site for initial screening before completing a brief online alcohol intervention (www.downyourdrink.org.uk). They will be asked to monitor their alcohol consumption for 1 week, and when they return to the laboratory 1 week later they will complete initial measures of inhibition and an alcohol association task before being randomly allocated to one of four groups. Three of the groups will undergo different types of inhibition training and one group will undergo sham training. They will be sent a link every other day (on average) for 28 days which will take them to a secure website hosting the training assessments and self-report measures of alcohol consumption. At the end of the 28-day training period, they will return to the test site and complete the measures of inhibition and the alcohol association task again. Finally, their alcohol consumption will be monitored via email at 2, 4 and 6 weeks after the end of the training period.

What are the possible benefits and risks of participating?
Participants may find the training too time-consuming, in which case they will be advised to withdraw from the study. Regular monitoring of their own alcohol consumption may prompt some participants to be concerned that they have a serious alcohol problem, in which case they are advised to withdraw from the study and contact their doctor.

Where is the study run from?
Study visits will take place in laboratories at the University of Liverpool (UK). The Internet intervention can be completed anywhere at the participant's convenience (e.g., home, work).

When is the study starting and how long is it expected to run for?
The study started in April 2014 and is expected to run until December 2015.

Who is funding the study?
The Medical Research Council (UK).

Who is the main contact?
Prof. Matt Field
mfield@liv.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Matt Field

ORCID ID

Contact details

Department of Psychological Sciences
University of Liverpool
Eleanor Rathbone Building
Bedford Street South
Liverpool
L69 7ZA
United Kingdom
+44(0)151 794 1124
mfield@liv.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

IPHS-1314-LB-238

Study information

Scientific title

A comparison of three types of web-based inhibition training for the reduction of alcohol consumption in problem drinkers

Acronym

Study hypothesis

Participants randomised to the active inhibition training groups will show reductions in alcohol consumption over four weeks of training and six weeks of follow-ups, compared to those who receive a control intervention. We do not make any a-priori hypotheses about differential effectiveness of the different forms of inhibition training, although we will compare them against each other. We are recruiting more participants than we require on the assumption that some participants will reduce their drinking before randomisation, and these participants may need to be excluded from primary analyses. We also predict psychological changes as a result of inhibition training: Cue-specific inhibition training will lead to improvements in cue-specific inhibition; General inhibition training will lead to improvements in general inhibition; and Alcohol No-Go training will lead to changes in automatic affective alcohol associations.

Ethics approval

University of Liverpool Research Ethics Committee, 07/02/2014, ref. IPHS-1314-LB-238

Study design

Phase II randomised double-blind controlled intervention. Single site.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Alcohol use disorders

Intervention

All participants will complete a brief online alcohol intervention (www.downyourdrink.org.uk) before one-week of self-monitoring of alcohol consumption, before randomisation to one of the following groups. All participants will complete their training sessions on the Internet every other day, on average, for 28 days (maximum of 14 training sessions in total):
1. Cue-Specific inhibition training. Participants will rapidly categorize alcohol and neutral pictures by pressing keys on their keyboard. On 50% of alcohol trials (25% of all trials) they will be required to inhibit this response whenever they see the stop signal (two red lines superimposed over the alcohol image). The stop signal initially occurs at 250 ms after stimulus presentation. Performance is tracked and with every successful training session (participant successfully inhibits on > 50% of inhibition trials) the subsequent training session becomes more difficult: the stop signal appears 10 ms later, which makes inhibition more difficult. There will be 200 trials (100 alcohol images and 100 neutral images), with 50 inhibition trials, in each training session.
2. General inhibition training. Participants will rapidly categorize arbitrary stimuli (the letters 'X' and 'O') by pressing keys on their keyboard. On 50% of trials they will be required to inhibit this response whenever they see the stop signal (two red lines superimposed over the letter). The stop signal initially occurs at 250 ms after stimulus presentation. Performance is tracked and with every successful training session (participant successfully inhibits on >50% of inhibition trials) the subsequent training session becomes more difficult: the stop signal appears 10 ms later, which makes inhibition more difficult. There will be 200 trials (100 letter X and 100 letter O), with 50 inhibition trials, in each training session.
3. Alcohol No-Go training. On each trial, an alcohol or neutral picture will be presented with the letter 'P' or 'R' superimposed in the corner of the picture. The letter P is the 'Go' cue that signifies that participants should rapidly respond by pressing the space bar. The letter R is the No-Go cue that signifies that participants should inhibit their response on that trial. The Go cue will always occur on neutral picture trials and the No-Go cue will always appear on alcohol picture trials, thus participants will always inhibit in response to alcohol pictures. There will be 200 trials (100 alcohol No-Go trials and 100 neutral Go trials) in each training session.
4. Control (sham training). Participants will rapidly categorize alcohol and neutral stimuli by pressing keys on their keyboard. There will be no inhibition trials. There will be 200 trials (100 alcohol images and 100 neutral images) in training session.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Alcohol consumption, specifically the total number of units consumed and the number of heavy drinking days. Heavy drinking days are defined as >60g of alcohol for men and >40g alcohol for women.

Secondary outcome measures

The number of abstinent days.

Overall trial start date

01/04/2014

Overall trial end date

01/12/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 25-65
2. Heavy drinker (14+ UK units per week if female, 21+ units per week if male)
3. Have computer and internet access

Note: 1 UK unit = 8g of alcohol.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

268

Participant exclusion criteria

1. History of alcohol or substance use disorder
2. Attention deficit hyperactivity disorder (ADHD)
3. Previous or current treatment for alcohol or substance use disorder or an impulse control disorder

Recruitment start date

01/04/2014

Recruitment end date

01/12/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Liverpool
Liverpool
L69 7ZA
United Kingdom

Sponsor information

Organisation

University of Liverpool (UK)

Sponsor details

c/o Liz Brignal
IPHS Research Ethics Committee
School of Psychology
Eleanor Rathbone Building
Bedford Street South
Liverpool
L69 7ZA
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Research council

Funder name

The Medical Research Council (UK), reference MR/K001558

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25090915

Publication citations

Additional files

Editorial Notes